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. 2021 May 28;2(3):628–634. doi: 10.1002/jha2.227

TABLE 3.

Targeted therapy regimens in treatment‐naïve CLL

Study Overview Key efficacy results
  • RESONATE‐2[14]

  • Phase 3 study of ibrutinib vs chlorambucil

  • mPFS: NR and 15.0 months for ibrutinib and chlorambucil group (HR, 0.146; 95% CI, 0.098‐0.218; P < .0001)

  • 5‐year PFS rate: 70% and 12% for ibrutinib and chlorambucil (HR, 0.146; 95% CI, 0.098‐0.218; P < .0001)

  • 5‐year OS rate: 83% and 68% for ibrutinib and chlorambucil (HR, 0.450; 95% CI, 0.266–0.761)

  • ECOG 1912[15]

  • Phase 3 study of ibrutinib plus rituximab vs FCR

  • 3‐year PFS rate: 89.4% and 72.9% for ibrutinib plus rituximab and FCR (HR, 0.35; 95% CI, 0.22 to 0.56; P < .001)

  • 3‐year OS rate: 98.8% and 91.5% for ibrutinib plus rituximab and FCR at 3 years; (HR, 0.17; 95% CI, 0.05 to 0.54; P < .001)

  • ALLIANCE[16]

  • Phase 3 study of BR vs ibrutinib vs ibrutinib plus rituximab

  • 2‐year PFS rate: 74%, 87% and 88% for BR, ibrutinib* alone and ibrutinib plus rituximab**; *(HR, 0.39; 95% CI, 0.26 to 0.58; P < .001); **(HR, 0.38; 95% CI, 0.25 to 0.59; P < .001)

  • mPFS: 43 months for BR and NR for ibrutinib and ibrutinib plus rituximab. There was no significant difference between the ibrutinib‐plus‐rituximab and the ibrutinib group with regard to progression‐free survival (HR, 1.00; 95% CI, 0.62 to 1.62; p = 0.49)

  • Phase 3 study of venetoclax plus obinutuzumab vs chlorambucil plus obinutuzumab

  • 2‐year PFS rate: 88.2% and 64.1% for venetoclax plus obinutuzumab and chlorambucil plus obinutuzumab (HR, 0.35; 95% CI, 0.23 to 0.53; P < .001).

  • 2‐year OS rate : 91.8% and 93.3% for venetoclax plus obinutuzumab and chlorambucil plus obinutuzumab (HR = 1.24; 95% CI, 0.64 to 2.40; p = 0.52)

  • iLLUMINATE[18]

  • Phase 3 study of ibrutinib plus obinutuzumab vs chlorambucil plus obinutuzumab

  • mPFS: NR and 19.0 months for ibrutinib plus obinutuzumab and chlorambucil plus obinutuzumab (HR, 0.23; 95% CI, 0.15 to 0.37; P < .0001)